POS0497 ROMOSOZUMAB AS A TREATMENT AFTER BISPHOSPHONATE OR FOR OSTEOPOROSIS WITH T-SCORE≦-2.5 IN CLINICAL PRACTICE
Authors: Y. Hirano, Y. Saito
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Romosozumab (ROMO) is an antisclerostin antibody that is used in the treatment of severe osteoporosis (OP). In March 2019, ROMO was approved for use in Japan for treating severe OP in clinical practice, causing an increase in its prescription in our institute. Although efficacy data for ROMO have been presented in clinical trials, there is a lack of real-world data. In our experience, ROMO treatment results in significant bone mineral density (BMD) gain in some patients, but not all. Therefore, understanding the efficacy of ROMO treatments in groups of patients frequency treated with ROMO in real-world clinical practice is essential. <h3>Objectives</h3> This study investigated the efficacy of a 12-month ROMO treatment in patients with OP and explored the efficacy as a treatment after bisphosphonate (BP) or for OP with T-score≦-2.5. <h3>Methods</h3> Our study included 64 patients with OP, who were started on ROMO treatment between June 2019and August 2021. The following information was collected: 1) baseline characteristics, 2) time-course of BMD (lumbar spine [LS] and total hip [TH]) and bone turnover markers (BTM; bone-specific alkaline phosphatase [BAP], type I procollagen-N-propeptide [P1NP], type I procollagen-N-propeptide [NTX], and tartrate-resistant acid phosphatase-5b [TRACP-5b]), 3) BMD outcomes as a treatment after BP or for OP patients with T-score≦-2.5. <h3>Results</h3> 1) The mean age of the participants was 72.4 years (59 female and five male). Of the 64 understudied patients, 84.4% had past insufficiency fractures, whereas 29.7% had been treated with concomitant prednisolone. Furthermore, 22 patients had primary OP, 24 had rheumatoid arthritis, 15 had glucocorticoid-induced OP, and three had other conditions. Pretreatments for OP were BP (44 patients), denosumab (6), selective estrogen receptor modulator (5), activated vitamin D (2), none (5), and daily teriparatide (1). 2) Both mean LS- and TH-BMD significantly increased in the patients for whom ROMO administration was continued for 12 months. The average percentage changes of LS- and TH-BMD were +6.6% and +1.6% at six months and +11.0% and +2.7% at 12 months, respectively. However, BAP and P1NP increased steeply at one month, followed by a gradual decrease. As observed, the average percentage changes of BAP and P1NP were +68.7% and +167.8% at one month, +47.6% and +84.3%at six months, and +20.2% and +41.5% at 12 months, respectively. The results also showed that TRACP-5b decreased from one to 12 months, with the average percentage changes being -15.1% at one month, -3.5% at six months, and -6.2% at 12 months. Moreover, NTX, a bone-resorptive marker, was slightly increased during ROMO treatment. 3) In 44 patients treated with ROMO after BP, the average percentage changes of LS- and TH-BMD were +5.7% and +1.7% at six months and +9.2% and +2.4% at 12 months, respectively. The average percentage changes of BAP and P1NP were +74.0% and +189.9% at one month, +39.5% and +65.3% at six months, and +17.7% and +36.6% at 12 months, respectively. TRACP-5b decreased from one to 12 months, with the average percentage changes being -14.7% at one month, -2.8% at six months, and -6.6% at 12 months. In 23 patients with baseline LS T-score≦-2.5, the average percentage changes of LS-BMD were +6.3% at six months and +11.8% at 12 months. 21.7% of patients reached LS T-score&gt;-2.5 at 12 months. In 24 patients with baseline TH T-score≦-2.5, the average percentage changes of LS-BMD were +2.3% at six months and +3.1% at 12 months. 20.8% of patients reached LS T-score&gt;-2.5 at 12 months. <h3>Conclusion</h3> ROMO treatments rapidly increased BMD, especially LS-BMD, and changed BTM after one month in both treatment after BP and OP with T-score≦-2.5. <h3>REFERENCES:</h3> NIL. <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> None Declared.